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Do 3D Printed Foot Orthoses Reduce Self-reported Pain?-a Randomised Controlled Study
The goal of this clinical trial is to compare the effects of 3D printed insoles versus prefabricated insoles in otherwise healthy subjects with flatfoot condition. The main question it aims to answer is: * If 3D printed insoles are better in terms of fit, weight, durability, comfort, and effectiveness compared to prefabricated insoles. * If 3D printed insoles are better in terms of reducing pain compared to prefabricated insoles. Participants will be divided in two groups. One group will receive 3D printed insoles and other group will wear prefabricated insoles for four weeks. After four weeks, researchers will record their feedback about their insoles which will help them to compare the two insoles.
The purpose of this research is to compare the effects of 3D printed insoles versus prefabricated insoles in flatfoot subjects. This study will recruit healthy adult subjects with flexible flat feet but otherwise good physical and mental health. They will be divided into groups of an equal number of people. Prefabricated insoles will be given to one group, while 3D printed insoles will be given to the other. Subjective feedback will be collected at week zero, when the subjects will be given the insoles to wear, and again at the end of fourth week. Statistical analysis will be used to determine whether or not there is a significant difference in the responses of the two groups. The results will help us in identifying which insoles are better than the other in terms of parameters described above.
Age
18 - 65 years
Sex
ALL
Healthy Volunteers
Yes
Medical Rehabilitation Hospital
Madinah, Medina Region, Saudi Arabia
Start Date
May 23, 2023
Primary Completion Date
July 30, 2023
Completion Date
August 8, 2023
Last Updated
August 25, 2023
95
ACTUAL participants
3D Printed Foot Orthosis
DEVICE
Prefabricated Foot Orthosis
DEVICE
Lead Sponsor
Taibah University
NCT07389343
NCT06562062
NCT06482580
Data Source & Attribution
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